Comparison of a Paper and Automated Bladder Diary in Pediatric Patients

Phase

N/A

Condition

Enuresis

Interstitial Cystitis

Overactive Bladder

Treatment

Paper bladder diary

Minze Diary Pod

Clinical Study ID

NCT06070675

BUN B3002023000056

Ages 6-12
All Genders

Study Summary

The purpose of this study is to compare an automated bladder diary (autoBD) to a paper bladder diary (pBD) on their level of agreement, patient compliance and satisfaction. It is a mixed methods, randomized 2x2 crossover trial. Pediatric patients (6 to 12 years) presenting to the clinic and identified as requiring a bladder diary will be recruited. Participants will be randomized either to group 1, where they complete the paper bladder diary (pBD) and then the automated bladder diary (autoBD), or to group 2, where they complete the autoBD and then the pBD. Both diaries are kept for at least 2 consecutive days with a wash-out period of 2 to 6 days between the two diaries. Mean differences and the level of agreement between the pBD and autoBD will be analysed using Bland Altman plots for key diary parameters.

After completion of each diary format, participants will complete a short online survey regarding compliance, satisfaction and their preference, if any. Finally, a selection of participants and their parents will be invited for an open-ended interview.

The participating healthcare professionals will be asked to score each pBD and autoBD on patient compliance when processing the diary. Furthermore, surveys and open-ended interviews will be conducted to assess their overall satisfaction of each diary type and their preference, if any.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Pediatric patients presenting to the clinic and identified as requiring a bladderdiary
Age: 6 to 12 years
Sex: male or female
Child and/or parent own and are able to operate a smartphone and/or tablet

Exclusion

Exclusion Criteria:

Change in urologic treatment during the data collection period
Inability to hold the Diary Pod while urinating
Inability to speak, read and write Dutch

Study Design

Paper bladder diary

October 01, 2023

January 01, 2026

Study Description

For some time now, patient compliance with paper bladder diaries is being questioned. Paper bladder diaries are often incomplete, unreliable and/or of low quality. Multiple electronic bladder diaries have been developed to overcome some of the limitations associated with paper bladder diaries. However, based on several comparison studies between paper and electronic bladder diaries, it is not clear whether an electronic format alone is truly superior to the paper format. The investigators want to introduce and evaluate the feasibility of a new type of bladder diary: an automated bladder diary. In contrast to an electronic diary, an automated diary automatically registers voiding data using a connected measuring device. An electronic diary simply eliminates the use of paper, but the patient still needs to measure the voided volumes with a urinary container and manually enter them in the electronic diary. The investigators believe an automated diary may lead to improved patient compliance by reducing the required efforts from the patient and instead provide guidance and prompts.

Connect with a study center

Imelda Ziekenhuis
Bonheiden, Antwerp 2820
Belgium
Active - Recruiting
UZA
Edegem, Antwerpen 2650
Belgium
Active - Recruiting
AZ Voorkempen
Malle, Antwerpen 2390
Belgium
Active - Recruiting
Privé praktijk dr. Katrien Klockaerts
Aalst, Oost-Vlaanderen 9300
Belgium
Active - Recruiting
ZNA Koningin Paola Kinderziekenhuis
Antwerpen, 2020
Belgium
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.